MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE LITHOTRIPSY TRANSDUCER.; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-T

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during preparation for use, the device exhibited an error during activation even after changing the probes.According to the reporter, per the legal manufacturer user¿s manual the service life of the device are 100 hours of use, however, the device per the reporter only has about 50 hours of use and an issue occurred.The site service field technician confirmed that there is no visible mechanical damage to the device.There was no patient involvement on this report.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number and investigation conclusion.Device evaluation confirmed the reported issue as the transducer was not producing any output and both the check probe box and error box illuminated red indicating the transducer was not working properly.There was no physical damage noted during device inspection.Device history records were reviewed and showed the product met all specifications upon release.The device was not opened up as the user has requested the device back although it is not a serviceable product.The device is fully tested for function after the manufacturing process, which means it was fully functional at this time.However with the causes specified the device needs to be sterilized by the user, which could have caused water ingress or a wire solder disconnect during the ultrasonic vibration.Therefore, likely causes of the reported failure are fluid ingress or an internal issue with the blue and brown wire.Olympus will continue to monitor complaints for this device.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10422357
• MDR Text Key: 219548415
• Report Number: 3011050570-2020-00045
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1